Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering

NCT ID: NCT05523037

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2022-08-15

Brief Summary

The incidence of postanesthetic shivering (PAS) after general anesthesia is affected by the anesthesia maintenance agents. This study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Detailed Description

Inadvertent perioperative hypothermia and postanesthetic shivering (PAS) are common after anesthesia regardless of anesthesia methods. The incidence of perioperative hypothermia and PAS after general anesthesia has been reported to be 37.5 to 77.2% and 20 to 70%, respectively. Shivering begins when vasoconstriction, a major mechanism to prevent body heat loss, is insufficient. PAS is one of the most common discomforts in the recovery room after general anesthesia. Therefore, PAS is common in hypothermic patients.

Volatile or intravenous anesthetics impair the autonomic thermoregulatory vasoconstriction which usually preserves core body temperature. However, benzodiazepines, such as midazolam, do not significantly impair thermoregulation control, even when used in combination with common opioid doses. Remimazolam, a novel benzodiazepine, has been reported for the thermoregulatory vasoconstriction threshold and onset time of vasoconstriction in terms of core body temperature in patients undergoing robotic-assisted and laparoscopic radical prostatectomy. It decreased the vasoconstriction threshold less than propofol, one of the intravenous anesthetics, and the onset of vasoconstriction was faster than propofol.

Investigators hypothesized that remimazolam reduced the incidence of hypothermia compared to sevoflurane, one of the volatile anesthetics, and eventually lowered the frequency of PAS. Therefore, this study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Conditions

Anesthesia; Hypothermia

Keywords

shivering; general anesthesia; laparoscopic surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group S

Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60.

For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane was administered

Sevoflurane

Intervention Type: DRUG

For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane and the concentration was adjusted by 1% stepwise titration

Group R

Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60.

For the maintenance of anesthesia, 1-2 mg/kg/h of remimazolam was continuously infused.

Remimazolam

Intervention Type: DRUG

For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused.

Interventions

Sevoflurane

For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane and the concentration was adjusted by 1% stepwise titration

Intervention Type: DRUG

Remimazolam

For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused.

Intervention Type: DRUG

Other Intervention Names

Byfavo®

Eligibility Criteria

Inclusion Criteria

• patients aged between 19 and 65 y, with ASA physical status classes I or II

Exclusion Criteria

• Patients with history such as thyroid disease, cardiopulmonary disease, blood coagulation disorder, liver dysfunction, cranial nerve disease, alcohol or drug abuse, a known allergy to the study drug, and those who had core body temperature > 38°C or < 36.5°C, BMI > 30 kg.m-2 or febrile illness were excluded. Patients who underwent surgery for less than 60 min, and those who did not consent to this study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wonkwang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheol Lee,MD,PhD,

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wonkwag UH

Iksan, Jeollabukdo, South Korea

Countries

South Korea

Other Identifiers

WonkwangUH10

Identifier Type: -

Identifier Source: org_study_id